ID
43483
Description
ODM derived from http://clinicaltrials.gov/show/NCT00844064
Lien
http://clinicaltrials.gov/show/NCT00844064
Mots-clés
Versions (3)
- 09/12/2013 09/12/2013 - Martin Dugas
- 16/04/2014 16/04/2014 - Julian Varghese
- 20/09/2021 20/09/2021 -
Téléchargé le
20 septembre 2021
DOI
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Licence
Creative Commons BY 4.0
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Eligibility NCT00844064 Pancreatic Neoplasms, Melanoma, Colorectal Neoplasms
Eligibility
- StudyEvent: Eligibility
Description
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Description
Patient unable to comply with the protocol regulations.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1321605
Description
Pregnant or lactating female.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C2828358
- UMLS CUI 2011AA
- C0086287
- SNOMED CT 2011_0131
- 248152002
- HL7 V3 2006_05
- F
Description
Antitumor radiation therapy within 12 weeks, tumor surgery within 4 weeks or any other therapy with established antitumor effects within 2 weeks prior to study entry.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0597025
- UMLS CUI 2011AA
- C0597029
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0920425
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C2348558
Description
The patient takes or is likely to need other prohibited concomitant medication. Administration of corticosteroids should be strictly avoided during the course of the study.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0683610
- UMLS CUI 2011AA
- C2347852
- UMLS CUI 2011AA
- C1533734
- SNOMED CT 2011_0131
- 416118004
- UMLS CUI 2011AA
- C0001617
- SNOMED CT 2011_0131
- 79440004
Description
Patient's participation in another clinical trial with investigational medication within 30 days prior to study entry.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0013230
Description
History of brain metastases. In the case of suspected brain metastases a CT scan of the skull will be performed (not mandatory in asymptomatic patients).
Type de données
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0220650
- MedDRA 14.1
- 10006128
- UMLS CUI 2011AA
- C0750557
- UMLS CUI 2011AA
- C0750491
- SNOMED CT 2011_0131
- 415684004
- UMLS CUI 2011AA
- C0220650
- MedDRA 14.1
- 10006128
- UMLS CUI 2011AA
- C0040405
- MedDRA 14.1
- 10011603
- UMLS CUI 2011AA
- C0037303
- SNOMED CT 2011_0131
- 89546000
- LOINC Version 232
- MTHU003024
Description
Clinically significant cardiovascular abnormalities such as refractory hypertension, congestive heart failure, unstable angina, or poorly controlled arrhythmia, or a myocardial infarction within 6 months prior to treatment.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0243050
- SNOMED CT 2011_0131
- 9904008
- MedDRA 14.1
- 10061054
- UMLS CUI 2011AA
- C0860493
- MedDRA 14.1
- 10038274
- UMLS CUI 2011AA
- C0018802
- SNOMED CT 2011_0131
- 42343007
- MedDRA 14.1
- 10007559
- LOINC Version 232
- MTHU020787
- ICD-10-CM Version 2010
- I50.9
- ICD-9-CM Version 2011
- 428.0
- UMLS CUI 2011AA
- C0002965
- SNOMED CT 2011_0131
- 4557003
- MedDRA 14.1
- 10002388
- ICD-10-CM Version 2010
- I20.0
- ICD-9-CM Version 2011
- 411.1
- UMLS CUI 2011AA
- C0205169
- SNOMED CT 2011_0131
- 556001
- UMLS CUI 2011AA
- C2587213
- SNOMED CT 2011_0131
- 31509003
- UMLS CUI 2011AA
- C0003811
- SNOMED CT 2011_0131
- 44808001
- MedDRA 14.1
- 10003119
- ICD-9-CM Version 2011
- 427.9
- UMLS CUI 2011AA
- C0027051
- SNOMED CT 2011_0131
- 22298006
- MedDRA 14.1
- 10028596
- LOINC Version 232
- MTHU035551
- ICD-10-CM Version 2010
- I21-I22
- ICD-9-CM Version 2011
- 410
- CTCAE 1105E
- E10152
Description
Gastric or duodenal ulcers within 6 months before study entry or is at risk of gastrointestinal ulceration due to high consumption of NSAIDs.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0038358
- SNOMED CT 2011_0131
- 397825006
- MedDRA 14.1
- 10017822
- ICD-10-CM Version 2010
- K25
- ICD-9-CM Version 2011
- 531
- CTCAE 1105E
- E10727
- UMLS CUI 2011AA
- C0013295
- SNOMED CT 2011_0131
- 367474008
- MedDRA 14.1
- 10013836
- ICD-10-CM Version 2010
- K26
- ICD-9-CM Version 2011
- 532
- CTCAE 1105E
- E10611
- UMLS CUI 2011AA
- C0035647
- SNOMED CT 2011_0131
- 30207005
- HL7 V3 2006_05
- RSK
- UMLS CUI 2011AA
- C1963975
- MedDRA 14.1
- 20000106
- UMLS CUI 2011AA
- CL420107
- UMLS CUI 2011AA
- C0003211
- SNOMED CT 2011_0131
- 16403005, 372665008
Description
An active infection with HIV, HBV, or HCV.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0009450
- SNOMED CT 2011_0131
- 257551009
- MedDRA 14.1
- 10021789
- UMLS CUI 2011AA
- C0019682
- SNOMED CT 2011_0131
- 19030005
- UMLS CUI 2011AA
- C0019169
- SNOMED CT 2011_0131
- 81665004
- UMLS CUI 2011AA
- C0220847
- SNOMED CT 2011_0131
- 62944002
- MedDRA 14.1
- 10019752
Description
Clinically significant acute viral, bacterial, or fungal infection.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0205178
- SNOMED CT 2011_0131
- 272118002
- UMLS CUI 2011AA
- C0042769
- SNOMED CT 2011_0131
- 34014006
- MedDRA 14.1
- 10047461
- ICD-10-CM Version 2010
- B34.9
- UMLS CUI 2011AA
- C0004623
- SNOMED CT 2011_0131
- 87628006
- MedDRA 14.1
- 10060945
- ICD-10-CM Version 2010
- A49.9
- UMLS CUI 2011AA
- C0026946
- SNOMED CT 2011_0131
- 3218000
- MedDRA 14.1
- 10017533
- ICD-10-CM Version 2010
- B35-B49
- ICD-9-CM Version 2011
- 110-118.99
Description
Acute medical problems that may be considered to become an unacceptable risk, or any conditions that might be contraindications for starting study treatment.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0205178
- SNOMED CT 2011_0131
- 272118002
- UMLS CUI 2011AA
- C1715372
- LOINC Version 232
- 44100-6
- UMLS CUI 2011AA
- C0678227
- SNOMED CT 2011_0131
- 23981006
- UMLS CUI 2011AA
- C1883420
- UMLS CUI 2011AA
- C0035647
- SNOMED CT 2011_0131
- 30207005
- HL7 V3 2006_05
- RSK
- UMLS CUI 2011AA
- C0348080
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
- UMLS CUI 2011AA
- C1301624
- SNOMED CT 2011_0131
- 397745006
Description
History of allergies to reagents used in this study.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0489531
- LOINC Version 232
- MTHU001065
- UMLS CUI 2011AA
- C0034760
- LOINC Version 232
- MTHU019417
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
Description
Drug abuse or extensive use of alcohol.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0237123
Description
Significant psychiatric disorders/ legal incapacity or limited legal capacity.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0004936
- SNOMED CT 2011_0131
- 74732009
- MedDRA 14.1
- 10037174
- ICD-10-CM Version 2010
- F99
- ICD-9-CM Version 2011
- 290-319.99
- UMLS CUI 2011AA
- C0332197
- SNOMED CT 2011_0131
- 2667000
- UMLS CUI 2011AA
- C0683673
- UMLS CUI 2011AA
- C0439801
- SNOMED CT 2011_0131
- 255469002
- UMLS CUI 2011AA
- C0683673
Description
History of Long QT Syndrome or QTc time ≥ 480 msec in screening/baseline ECGs. The average QTc time is to be calculated from three separate ECGs performed prior to start of infusion: two ECGs performed at Screening/Baseline (with a minimum 1-hour interval in between) and one performed within 1 hour prior to start of infusion.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0023976
- SNOMED CT 2011_0131
- 9651007
- MedDRA 14.1
- 10024803
- ICD-10-CM Version 2010
- I45.81
- ICD-9-CM Version 2011
- 426.82
- UMLS CUI 2011AA
- C0860814
- MedDRA 14.1
- 10037707
- UMLS CUI 2011AA
- C1409616
- UMLS CUI 2011AA
- C1442488
- UMLS CUI 2011AA
- C1623258
- SNOMED CT 2011_0131
- 46825001
- MedDRA 14.1
- 10014084
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- StudyEvent: Eligibility
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10060945 (MedDRA 14.1)
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3218000 (SNOMED CT 2011_0131)
10017533 (MedDRA 14.1)
B35-B49 (ICD-10-CM Version 2010)
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272118002 (SNOMED CT 2011_0131)
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392521001 (SNOMED CT 2011_0131)
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10024803 (MedDRA 14.1)
I45.81 (ICD-10-CM Version 2010)
426.82 (ICD-9-CM Version 2011)
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10037707 (MedDRA 14.1)
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